Dear Colleague,
DMF or Certificate of Suitabiliy (COS) is mandatory for active ingredients
but not for excipients.
Regards,
Bulcsu Herenyi, Ph.D.
RA Director
ICN Hungary Co. Ltd.
e-mail: bherenyi@icnpharm.com
P.S.: I wish all members of this group Merry Christmas and a Happy,
Successful New Year!
"P.K.NANDI"
<nandipk@alembic.co.in To: "RegAffairs"
>
<RegAffairs@pharmweb1.man.ac.uk>
Sent by: cc:
<RegAffairs@pharmweb1. Subject: DMF
man.ac.uk>
21/12/2001 11:10
Please respond to
"RegAffairs"
Dear members
Is the use of DMF grade actives and inactives (excipients) manadatory
for a generic formulation to be marketed in Europe?
--------------------------------------------
P.K.NANDI
nandipk@alembic.co.in
ALEMBIC LIMITED
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